NCT05980507撤回1 期
An Open Label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ICI201 Infusion in Relapsed/Refractory Multiple Myeloma
The First Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家开始时间: 2023年10月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
An open label, single-arm clinical study evaluating the safety and efficacy of ICI201 infusion in relapsed/refractory multiple myeloma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
- •Subjects must have previously received at least 3 anti-myeloma regimens. Subjects must have documented disease progression (according to IMWG criteria) during or within 12 months of completing their last anti-myeloma regimen prior to study entry; and prior regimens must have included proteasome inhibitor (PI) and immunomodulatory drug (IMiD).
- •Measurable disease as defined by the protocol
- •ECOG score is 0 or
- •Expected survival time ≥12 weeks.
- •GPRC5D positive expression in bone marrow plasma cells
排除标准
- •Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants drugs.
- •Patients who received autologous hematopoietic stem cell transplantation (ASCT) or prior allogeneic hematopoietic stem cell transplantation (ALLo-HSCT) within 12 weeks prior to mononuclear cell collection.
- •Screening subjects who were receiving systemic steroids during the previous 7 days or who were determined by the investigator to require long-term systemic steroid use during treatment (except for inhaled or topical use, except at doses < 10mg/ day).
- •Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg).
- •Patients who have recieved GPRC5D-targeted therapy
研究组 & 干预措施
ICI201
Experimental
干预措施: ICI201 (Drug)
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: Time Frame: 28 days post ICI201 administration
Dose limiting toxicity (DLT)
Incidence and severity of all adverse events related to study drug
时间窗: Time Frame: 2 years post ICI201 administration
Incidence and severity of all adverse events related to study drug
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y002#Relapsed/Refractory Multiple MyelomaNCT05266768Chunrui Li36
已完成
1 期
Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Efficacy of IBI346#CIBI346Y001#Relapsed/Refractory Multiple MyelomaNCT05270928The First Affiliated Hospital of Soochow University6
已完成
1 期
Study in Blood Stage Malaria Infection After DVI of Cryopreserved P. Falciparum (NF54 Strain) SporozoitesMalaria,FalciparumParasitemiaProtozoan InfectionsParasitic DiseaseNCT04310085Medicines for Malaria Venture16
招募中
1 期
CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence After Surgical ResectionHCCNCT06560827CARsgen Therapeutics Co., Ltd.30
招募中
1 期
A Study to Evaluate the Efficacy and Safety of CT041 After Adjuvant Chemotherapy for Pancreatic CancerPancreatic CancerNCT05911217CARsgen Therapeutics Co., Ltd.20